NORCROSS, GA--(Marketwired - Sep 11, 2013) - RayBiotech, Inc. announced today that the company has been awarded ISO 13485: 2003 certification with respect to its compliance in the manufacture of in vitro diagnostics kits to be provided to the research community. The ISO 13485 award applies to multivariant antibody arrays, enzyme-linked immunosorbent assays (ELISAs) as well as membrane and glass format arrays and reagents. ISO 13485 is the International Organization for Standardization's certification that the fundamentals of quality management are in place and actively implemented as formal systems within the organization. The ISO 13485 compliance certification is in addition to the company's formal compliance under Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), and it further confirms RayBiotech's commitment to quality control and quality assurance for all of its products and services.
Commenting on the certification, RayBiotech's President, Chief Operating Officer and Co-Founder, Rani Huang stated, "We are delighted to receive formal certification of ISO compliance for our array and ELISA-related product lines. This new level of quality assurance perfectly complements our existing cGLP and cGMP quality programs and signifies that RayBiotech continuously strives to achieve the highest level of quality possible in the manufacture of products and implementation of services."
RayBiotech's Quality Manager, Leanne Wakelin added, "RayBiotech Inc. is committed to providing high quality products and services to its customers and in doing so has now achieved medical device certification to ISO 13485 requirements. This applies to our production facility and testing services facility and adds to our compliance regarding GLP/GMP FDA regulations. As we look to the future, we will continue to ensure that all our products and testing services maintain this high standard of quality with our continual improvement program in place."
About RayBiotech, Inc.
In 2001 RayBiotech (http://www.raybiotech.com) introduced the first commercially available cytokine antibody array. With a focus on translating scientific knowledge into improved health, RayBiotech continues to pioneer advances in high-throughput platforms for identifying disease mechanisms, screening and validation of biomarkers and identification of drug targets. RayBiotech products are manufactured under GMP and ISO 13485: 2003 compliance and are featured in thousands of publications, including: Nature, Nature Medicine, Cell, Lancet, PNAS and many others. Offering the largest selection of protein arrays, RayBiotech has established a reputation for high quality and innovation in the research community. A spin-off from Emory University, RayBiotech is privately owned, with headquarters in metropolitan Atlanta.
- Health Care Industry
Rob Burgess, PhD
Director, Business Development